Protalex Announces First Patient Dosed in European Phase Ib Study of PRTX-100 for Immune Thrombocytopenia

FLORHAM PARK, N.J.--
Protalex, Inc. (OTCQB:PRTX), a clinical-stage biopharmaceutical company,
today announced dosing of the first patient in its European Phase Ib
study of PRTX-100 in adults with persistent/chronic Immune
Thrombocytopenia (ITP) (the PRTX-100-203 Study). PRTX-100, Protalex’s
lead drug candidate, is a highly purified form of Staphylococcal protein
A (SpA), which was granted Orphan Drug Designation in Europe and the
U.S. for the treatment of ITP. A similar Phase I/II clinical study of
PRTX-100 is underway in the U.S. (the PRTX-100-202 Study). PRTX-100 is
also the subject of ongoing clinical development in Rheumatoid Arthritis
(RA).

The 203 Study is an open-label, dose-escalation study that will enroll
up to 30 patients in as many as five cohorts at five to six clinical
centers in France. Each patient will receive four weekly intravenous
doses of PRTX-100 and will be monitored for up to 48 weeks thereafter.
The primary study endpoint of the 203 Study is safety. Secondary
endpoints include platelet response, immunogenicity and pharmacokinetics.

“The 203 Study is designed to evaluate the safety and efficacy of
PRTX-100 in a range of doses. Combined with the recently initiated
U.S-based 202 Study, the 203 Study will provide important data to
support our continued development plans for PRTX-100 in ITP. We look
forward to continuing enrollment in these Phase I/II clinical trials in
2016,” stated Richard J. Francovitch, Ph.D., Protalex’s Vice
President-ITP Programs. “Our enthusiasm for the ITP clinical development
program is further supported by data from preclinical studies of
PRTX-100 in a sophisticated animal model of ITP that were presented at
the American Society of Hematology (ASH) meeting last month. We believe
PRTX-100 may offer a promising new approach to treat patients with ITP.”

About Immune Thrombocytopenia (ITP)

ITP is an autoimmune-mediated condition characterized by bruising and
increased bleeding as a result of immune-mediated accelerated
destruction of platelets and impaired production of platelets. The
diagnosis of ITP is based upon a low platelet count, usually less than
100,000 per microliter of blood, in the absence of other possible causes
of reduced platelet numbers such as an underlying illness or medication.

About PRTX-100

PRTX-100, a new generation immunomodulatory therapy, is a highly
purified form of SpA, an immunomodulatory protein known to modify
aspects of the human immune system. PRTX-100 has the ability, at very
low concentrations, to bind to human B-lymphocytes and macrophages and
to modulate immune processes. Preclinical data indicate that PRTX-100
may have the potential to treat ITP by reducing the immune-mediated
destruction of the platelets. The two most recently approved drugs used
to treat ITP, Nplate® (romiplostin) and Promacta®/Revolade™
(eltrombopag) both increase the production of platelets but do not
appear to affect the underlying platelet destruction process. The
safety, tolerability and pharmacokinetics of PRTX-100 have been
characterized in five clinical studies. PRTX-100 was recently granted
Orphan Drug Designation in the U.S. and Europe for the treatment of ITP.
In two Phase Ib clinical trials in adult patients with active Rheumatoid
Arthritis (RA), PRTX-100 was generally safe and well tolerated at all
dose levels, and at certain higher doses more patients showed
improvement in measures of RA disease activity than did patients at the
lower dose or placebo cohorts.

About Protalex, Inc.

Protalex, Inc. is a clinical-stage biopharmaceutical company focused on
the development of a class of drugs for treating autoimmune and
inflammatory diseases including RA and ITP. In the U.S., Protalex has
open INDs in RA and ITP. Please visit Protalex’s website at www.protalex.com
to learn more about Protalex and its lead drug candidate, PRTX-100.

Forward-Looking Statements

Statements in this press release that are not statements of historical
or current fact constitute "forward-looking statements." Such
forward-looking statements involve known and unknown risks,
uncertainties and other unknown factors that could cause the Company's
actual operating or clinical results to be materially different from any
historical results or from any future results expressed or implied by
such forward-looking statements. In addition to statements that
explicitly describe these risks and uncertainties, readers are urged to
consider statements that contain terms such as "believes," "belief,"
"expects," "expect," "intends," "intend," "anticipate," "anticipates,"
"plans," "plan," to be uncertain and forward-looking. The
forward-looking statements contained herein are also subject generally
to other risks and uncertainties that are described from time to time in
the Company's filings with Securities and Exchange Commission.